This invention relates to bone anchor delivery devices and more specifically to a bone anchor delivery device having an articulating head.
Bone anchors are used in connection with various surgical procedures to internally anchor one or more sutures to a bone substrate. For example, bone anchors are used in cystourethropexy and vaginal sling procedures to anchor sutures used in connection with a variety of sling materials to manage urinary incontinence. Traditionally, bone anchors, or bone screws as they are alternatively called, are fixed to the bone by making an incision through the soft tissue, such as the vaginal mucosa, driving the anchor into the pubic bone using a drill and suturing the incision closed. However, this procedure is time consuming and difficult to accomplish through the vaginal opening. Not only must the surgeon close the mucosal incision, the procedure presents a technically difficult suturing angle. As a result, the tension application of the graft on the urethra is usually less than optimal.
To reduce the difficulties associated with the traditional suturing angle, various bone anchor delivery devices were developed, such as the xe2x80x9cIn-Fastxe2x80x9d device available from American Medical Systems, Minnetonka, Minnesota, which features a rigid, offset U-shape design with an additional handle and a screw positioned at the shorter tip of the xe2x80x9cUxe2x80x9d. The U-shape creates a 90 degree angle to allow the lower portion of the device to be inserted into the vagina and pressed against the posterior pubic bone. An actuator located on the hand is then triggered and the bone screw is screwed into the pubic bone directly through the soft, mucosal tissue.
Although currently available bone anchor delivery devices, such as the xe2x80x9cIn-Fastxe2x80x9d device improve somewhat on the traditional procedure, these rigid devices do not provide the necessary flexibility needed to adequately accommodate anatomical variations among patients. For example, these rigid devices do not allow the surgeon to adjust the angle of the screw relative to the handle as needed to negotiate the variety of anatomical variations within female pelves. These rigid devices also restrict the placement of bone-anchors in those women with a large pre-pubic amount of adipose tissue and those with a narrow pubic arch.
It is therefore a primary object of this invention to provide a bone anchor delivery device with an articulating head.
It is a further object of this invention to provide a bone anchor delivery device which enables the surgeon to vary the angle between the handle and the bone anchor to accommodate various surgical procedures and to negotiate the variety of anatomical variations within female pelves.
It is a further object of this invention to provide a bone anchor delivery device which enables the surgeon to adjust the placement of bone-anchors in those women with a large pre-pubic amount of adipose tissue nor those with a narrow pubic arch.
It is a further object of this invention to provide a delivery device for a bone anchor attached to a suture which includes a self-securing cinch and/or crimp to obviate the need to tie off the suture.
It is a further object of this invention to provide a self-contained, bone anchor delivery device with an articulating head that includes a power source, a motor and a drive shaft for the bone anchor.
It is further object of this invention to provide a bone anchor delivery device with a disposable, articulating head.
It is further object of this invention to provide a bone anchor delivery device that improves the tension on the resulting graft.
The preferred embodiment of the delivery device of the invention for fixing an anchor to a bone, comprises: a distal delivery member which comprises, an articulating head, a bone anchor attached to a suture, and a means for articulating the head relative to the hand piece; and a proximal hand piece which comprises a means for driving the anchor into the bone and a means for attaching the distal delivery member to the hand piece; wherein the means for driving preferably comprises a motor, and a torquing device and the hand piece preferably further comprises a self-contained power source, such as a battery.
The head is preferably capable of articulating over at least a range of about 30 degrees in one or more directions and preferably over a range of at least about 30 degrees in at least both a vertical and a horizontal direction in increments of about five degrees. The means for articulating may comprise a ball and socket joint and/or a position locking means such as one or more corresponding splines or detents.
The distal delivery member is preferably disposable and preferably comprises an exit for the suture and the suture preferably comprises a means for securing the suture such as a cinching and/or crimping device.
Another preferred embodiment of the delivery device of the invention for fixing an anchor to a bone, comprises: a distal delivery member which comprises, an articulating head, a bone anchor attached to a suture, a shaft for driving the anchor into the bone, and a means for articulating the head relative to the hand piece in one or more directions; and a proximal hand piece which comprises, a means for attaching the distal delivery member to the hand piece, a motor, and a device for torquing the shaft; wherein the hand piece may further comprises a self-contained power source; and wherein the distal delivery member is preferably disposable.